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Completed

NCT Number: NCT04795245

Non-interventional Study for Real-world Data of Afatinib Treatment in First-line Setting and of Subsequent Therapies for Patients With Advanced Epidermal Growth Factor Receptor (EGFR) Mutation-positive Lung Adenocarcinoma

The primary objective is to confirm Time on Treatment (TOT) related to afatinib treatment as first-line therapy in patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive Non-Small Cell Lung Cancer (NSCLC).

The observation in the real-world setting of the time from the start of the first-line afatinib until the end of subsequent treatment in this study will provide insights on the sequence of treatment for patients. The Japanese healthcare system will enable this study to evaluate multiple treatment options after afatinib treatment.

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Key information

Conditions

Non-squamous, Non-Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nippon Boehringer Ingelheim Co., Ltd.

Tokyo, 141-6017, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive advanced Non-Small Cell Lung Cancer (NSCLC)
  • Patients who were/are treated with afatinib in the first-line setting at least 20 months* prior to data entry
  • Patients 20 years of age or older at the time of consent
  • Patients who provided consent to participate in this study (for cases of death or lost to follow-up, instructions from the Ethic Committee (EC)/Institutional Review Board (IRB) at each site should be followed) * Inclusion will be restricted to patients with treatment initiation with afatinib at least 20 months prior to enrolment to avoid early censoring.

Exclusion criteria

  • Any contraindication to afatinib as specified in the label of Giotrif®
  • Patients treated with afatinib within an interventional trial
  • Patients with active brain metastases at start of afatinib treatment* * Patients with non-active brain metastases (asymptomatic state) are eligible.

Treatment and study plan

afatinib

Drug

afatinib

Other names: Giotrif®

Primary outcomes

  1. Time on Treatment (TOT) With Afatinib in First-line TOT (TOT1)

    Time frame: From start of afatinib as first line treatment up to 18 months and up to 36 months.

    Time on Treatment (TOT) with afatinib in first-line TOT (TOT1). This was assessed as the time from the start of afatinib as first-line treatment until the end of afatinib treatment or death date by any cause, whichever occurs first. If patients did not discontinue first-line treatment with afatinib and did not die at the data extraction, they were censored on the date they were last verified to have been on first-line treatment with afatinib. The survival probability rate (95% confidence interval) against time to first-line treatment failure at 18 months and at 36 months is reported.

Secondary outcomes

  1. Time on Treatment From the Start of Afatinib Until End of Subsequent Therapies in the Second-line Setting or Death by Any Cause (TOT)

    Time frame: From start of afatinib up to 18 months and up to 36 months.

    Time on treatment from the start of afatinib until end of subsequent therapies in the second-line setting or death by any cause (TOT). If patients did not discontinue second-line treatment and did not die at the data extraction, they were censored on the date they are last verified to have been on second-line treatment. If patients were on first-line treatment and did not move to second-line treatment at the data extraction, ToT is same as first-line TOT (ToT1) for these patients. The survival probability rate (95% confidence interval) against time to treatment failure at 18 months and at 36 months is reported.

  2. Time on Treatment From Start of the Second-line Treatment Until End of the Second-line Treatment or Death by Any Cause (TOT2)

    Time frame: From start of afatinib as second line treatment up to 18 months and up to 36 months.

    Time on treatment from start of the second-line treatment until end of the second-line treatment or death by any cause (TOT2). If patients did not discontinue second-line treatment and did not die at the data extraction, they were censored on the date they are last verified to have been on second-line treatment. The survival probability rate (95% confidence interval) against time to second-line treatment failure at 18 months and at 36 months is reported.

  3. Overall Survival

    Time frame: From start of afatinib up to 18 months and up to 36 months.

    If patients did not die at the data extraction, they were censored on the date they are last verified to be alive. The survival probability rate (95% confidence interval) at 18 months and at 36 months is reported.

  4. Time to Initial Dose Reduction of Afatinib

    Time frame: From start of afatinib up to 18 months and up to 36 months.

    Time to initial dose reduction of afatinib. If patients did not reduce initial dose of afatinib at the data extraction, they were censored on the date they were last verified to have been on the initial dose of afatinib or increased dose of afatinib. The survival probability rate (95% confidence interval) against time to initial dose reduction of afatinib at 18 months and 36 months is reported.

  5. Percentage of Participants With Dose Modifications of Afatinib

    Time frame: From start of data extraction until end of data extraction, up to 586 days.

    Percentage of participants with dose modifications of afatinib.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

J-REGISTER: Japanese REal-world Data for Treatment of Afatinib (GIotrif®) in First-line Setting and Subsequent Therapies for Patients With Advanced EGFR Mutation-positive Lung Adenocarcinoma

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 12, 2021
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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